Treatment of Acetaminophen Toxicity With N-acetylcysteine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Martha Blackford, Akron Children's Hospital
ClinicalTrials.gov Identifier:
NCT00725179
First received: July 25, 2008
Last updated: September 8, 2011
Last verified: September 2011
  Purpose

Retrospective chart review of patients who received N-acetylcysteine for APAP toxicity to assess length of oral vs IV treatment and overall healthcare costs.


Condition
Acetaminophen Toxicity

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Treatment of Acetaminophen Toxicity With Intravenous vs Oral N-acetylcysteine: A Retrospective Review

Resource links provided by NLM:


Further study details as provided by Akron Children's Hospital:

Primary Outcome Measures:
  • Duration of oral vs IV NAC treatment in hours [ Time Frame: From admission to discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall healthcare costs associated with IV vs Oral NAC treatment [ Time Frame: From admission to discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: August 2008
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients receiving oral NAC treatment
2
Patients receiving IV NAC treatment

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric and adolescent patients with acetaminophen toxicity

Criteria

Inclusion Criteria:

  • Admitted to CHMCA between June 1, 2004 to May 31, 2008 with a qualifying ICD-9 diagnosis code for the following APAP overdose situations; poisoning, accidental, suicide attempt, therapeutic use, assault, and undetermined (965.4, E850.4, E950.0, E935.4, E962.0, E980.0)
  • Serum APAP concentrations ≥ 150 g/mL at 4 hours or a serum concentration above the possible hepatotoxic line on the Rumack-Matthew's nomogram if obtained > 4 hours post ingestion
  • Between the ages of 0-21 years

Exclusion Criteria:

  • Serum APAP concentrations are not actually documented
  • Patient did not receive oral or IV NAC treatment
  • Patient has a preexisting liver disease such as cirrhosis or hepatitis C
  • Patient > 21 years of age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00725179

Locations
United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44703
Sponsors and Collaborators
Akron Children's Hospital
Investigators
Principal Investigator: Martha Blackford, PharmD CHMCA
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Martha Blackford, PharmD, Akron Children's Hospital
ClinicalTrials.gov Identifier: NCT00725179     History of Changes
Other Study ID Numbers: APAP & NAC
Study First Received: July 25, 2008
Last Updated: September 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Akron Children's Hospital:
acetaminophen toxicity
n-acetylcysteine
liver toxicity

Additional relevant MeSH terms:
Acetaminophen
Acetylcysteine
N-monoacetylcystine
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antidotes

ClinicalTrials.gov processed this record on April 17, 2014